EP4512484A3 - Excipients for nicotine-containing therapeutic compositions - Google Patents

Excipients for nicotine-containing therapeutic compositions Download PDF

Info

Publication number
EP4512484A3
EP4512484A3 EP24216877.1A EP24216877A EP4512484A3 EP 4512484 A3 EP4512484 A3 EP 4512484A3 EP 24216877 A EP24216877 A EP 24216877A EP 4512484 A3 EP4512484 A3 EP 4512484A3
Authority
EP
European Patent Office
Prior art keywords
nicotine
active ingredient
microcrystalline cellulose
porous substrate
carrier
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24216877.1A
Other languages
German (de)
French (fr)
Other versions
EP4512484A2 (en
Inventor
August Joseph Borschke
Darrell Holton
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Modoral Brands Inc
Original Assignee
Modoral Brands Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=47144140&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP4512484(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Modoral Brands Inc filed Critical Modoral Brands Inc
Publication of EP4512484A2 publication Critical patent/EP4512484A2/en
Publication of EP4512484A3 publication Critical patent/EP4512484A3/en
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/465—Nicotine; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A61K9/0058—Chewing gums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/26—Psychostimulants, e.g. nicotine, cocaine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/34—Tobacco-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Psychiatry (AREA)
  • Addiction (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

A composition intended to be employed for therapeutic purposes incorporates an active ingredient (e.g., a source of nicotine) and at a non-active ingredient that is carried by a porous substrate. The non-active ingredient can be a substance that has the capability of affecting the pH of the biological system to which it is applied (e.g., basic substance and/or buffering agent is sorbed onto the porous carrier, so as to be in intimate contact with that carrier). Representative forms of nicotine include free base (e.g., as a mixture of nicotine and microcrystalline cellulose), a nicotine salt (e.g., as nicotine bitartrate) and nicotine polacrilex. The basic substance can be sodium carbonate, and the porous substrate can be microcrystalline cellulose. The composition is useful for treatment of central nervous system conditions, diseases, and disorders, and can be used as a nicotine replacement therapy.
EP24216877.1A 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions Pending EP4512484A3 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US13/278,877 US9907748B2 (en) 2011-10-21 2011-10-21 Excipients for nicotine-containing therapeutic compositions
PCT/US2012/061023 WO2013059592A1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions
EP20174169.1A EP3744313B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions
EP12783465.3A EP2768479B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
EP12783465.3A Division EP2768479B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions
EP20174169.1A Division EP3744313B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions

Publications (2)

Publication Number Publication Date
EP4512484A2 EP4512484A2 (en) 2025-02-26
EP4512484A3 true EP4512484A3 (en) 2025-05-07

Family

ID=47144140

Family Applications (3)

Application Number Title Priority Date Filing Date
EP24216877.1A Pending EP4512484A3 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions
EP20174169.1A Active EP3744313B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions
EP12783465.3A Revoked EP2768479B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions

Family Applications After (2)

Application Number Title Priority Date Filing Date
EP20174169.1A Active EP3744313B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions
EP12783465.3A Revoked EP2768479B1 (en) 2011-10-21 2012-10-19 Excipients for nicotine-containing therapeutic compositions

Country Status (10)

Country Link
US (1) US9907748B2 (en)
EP (3) EP4512484A3 (en)
JP (1) JP6228544B2 (en)
CN (1) CN104114151A (en)
DK (2) DK2768479T3 (en)
ES (1) ES2811113T3 (en)
FI (1) FI3744313T3 (en)
HU (1) HUE051459T2 (en)
PL (2) PL2768479T3 (en)
WO (1) WO2013059592A1 (en)

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US10959456B2 (en) 2014-09-12 2021-03-30 R.J. Reynolds Tobacco Company Nonwoven pouch comprising heat sealable binder fiber
US9968125B2 (en) 2015-01-09 2018-05-15 Philip Morris Products S.A. Nicotine—diketopiperazine microparticle formulations and methods of making the same
US11224594B2 (en) 2015-09-16 2022-01-18 Philip Morris Products S.A. Nicotine formulations and methods of making and using the same
US20170071248A1 (en) 2015-09-16 2017-03-16 Sansa Corporation (Barbados) Inc. System and Method for Controlling the Harshness of Nicotine-Based Dry Powder Formulations
US10149844B2 (en) 2015-09-16 2018-12-11 Philip Morris Products S.A. Inhalable nicotine formulations, and methods of making and using thereof
US9585835B1 (en) 2015-09-16 2017-03-07 Sansa Corporation (Barbados) Inc. Inhalable nicotine formulations and methods of making and using the same
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US12137723B2 (en) 2019-12-09 2024-11-12 Nicoventures Trading Limited Oral products with active ingredient combinations
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US11382861B1 (en) * 2020-12-17 2022-07-12 Nirajkumar Karneshbhai Patel Nicotine pouch
EP4358748A1 (en) 2021-06-25 2024-05-01 Nicoventures Trading Limited Oral products and method of manufacture
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JP6228544B2 (en) 2017-11-08
WO2013059592A1 (en) 2013-04-25
DK2768479T3 (en) 2020-08-10
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HUE051459T2 (en) 2021-03-01
EP3744313B1 (en) 2024-12-04
DK3744313T3 (en) 2025-03-03
ES2811113T3 (en) 2021-03-10
EP4512484A2 (en) 2025-02-26
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